Part 11 sets forth criteria under which FDA considers electronic records, electronic signatures and handwritten signatures executed to electronic records to be trustworthy, reliable and generally equivalent to paper records and handwritten signatures executed on paper. These criteria include audits, system validations, audit trails and certain documentation. Vendors (including ourselves) cannot provide software that complies with all these Part 11 requirements.

We do provide software that has features (such as audit trails and electronic signatures) that enable customers to comply with various regulations, but only after the customer has gone through our Computer System Validation Service. We provide Computer System Validation Service for several instrument platforms. Instruments for which we offer Computer System Validation Service.

GxP collectively refers to a set of quality-related regulations and guidelines that are followed by regulated industries such as pharmaceutical and life sciences to help ensure that products are safe and function as intended.

Good Manufacturing Practices (GMP)—methods, facilities and controls used in the manufacture, packaging, labeling, storage, installation and servicing of products to ensure their safety and effectiveness

No, a risk assessment is not mandatory, although it does help customers optimize their validation strategy. In keeping with GAMP5, a risk-managed strategy will help reduce both the costs of validation and exposure to regulatory risk. We provide a Risk Assessment Service that can be a starting point to help you with your compliance efforts.

No, a vendor audit is just one step in your validation process. FDA regulations provide that Computer System Validation involves testing the system in the customer environment, and is ultimately the customer’s responsibility. The customer is also responsible for implementing procedural and administrative controls for regulatory compliance. The Risk Assessment Service provided by us includes a Computer System Validation that helps to identify computer system gaps and provides recommendations to improve your laboratory’s efficiency.

21 CFR Part 11 applies to records, required by FDA’s regulations, that are in electronic form and are created, modified, maintained, archived, retrieved or transmitted. Part 11 also applies to electronic records submitted to FDA.

Good Automated Manufacturing Practices Version 5 (GAMP5), specifies that regulated companies have the responsibility for documentation, approval, and compliance of each element of the computerized system lifecycle. GAMP5 provides that such companies utilize vendor audits to ensure quality of the product and development process. The guide also suggests that regulated companies maximize supplier involvement to help with gathering requirements, creation of functional and other specifications, system configuration, testing, support, maintenance, and system retirement.

Yes. To help you control validation costs, we offer discounts when you sign up for validation services on multiple systems. If you require further customization for your validation process, or a broader scope of validation services, please contact one of our sales or service representatives by email at service.sales@lifetech.com, or via telephone at 800 327 3002 (toll free in the US only). To contact a compliance and validation expert directly, please email complianceservices@lifetech.com.

TERMS

What is an IQ?

Instrument Qualification (IQ) procedures verify at the time of the testing, that instrumentation is delivered and installed according to the stringent specifications set by Life Technologies, documenting the shipment integrity, components, and compatibility with the system configuration.

What is an OQ/IPV?

Operation Qualification/Instrument Performance Verification (OQ/IPV) verifies and records an instrument’s ability to meet specified performance criteria after installation, repetitive use, relocation, or other major service events. The OQ/IPV service involves comprehensive testing of the complete system using established conditions and known sample characteristics, verifying the accuracy and precision of the instrument. Instruments should be regularly tested to confirm high-quality performance and identify possible impact due to normal wear or inadequate user maintenance.

What is an FSE?

A Field Service Engineer (FSE) is an experienced and certified representative trained to repair and service Applied Biosystems™, Invitrogen™, and Ion Torrent™ instruments using only factory-certified replacement parts.

What is the Remote Service Center?

The Remote Service Center is a phone-in facility where senior service engineers aid in solving instrument and computer validation problems before an FSE is sent out to your laboratory. Often a Remote Service Center representative can help fix your problem quickly and easily, thereby eliminating the need for a field visit.